Patch agent

ABSTRACT

The patch agent of the present invention is a patch agent comprising a support made of a synthetic fiber and an adhesive layer mounted on the support, and having a bending resistance of 10 to 30 mm and a probe tack value of 0.25 to 1.2 N. The patch agent of the present invention can fully be prevented from peeling off at the time of application and can fully suppress the rash of skin and the pain upon peeling.

CROSS-REFERENCED APPLICATIONS

This application is a National phase of International ApplicationPCT/JP01/03806, filed May 2, 2001, which designated the U.S. and thatInternational Application was not published under PCT Article 21(2) inEnglish.

TECHNICAL FIELD

The present invention relates to a patch agent; and, more specifically,to a patch agent which can fully be prevented from peeling off whenemployed in a plaster agent or poultice agent, whereas the rash of skinand the pain upon peeling are suppressed.

BACKGROUND ART

A number of medical patch agents, such as transdermal absorbent andadhesive plaster tape, in which an adhesive layer containing a medicineis mounted on a support have conventionally been made. While such patchagents are required to have such characteristics that they do not peeloff even when applied to parts such as joints and faces where movementsare large and skins expand and constrict drastically, and neither rashnor flare occurs in the skin even when applied thereto for a long periodof time. In the conventional patch agents, those hard to peel off havebeen likely to generate a rash or flare in the skin and accompany a painupon peeling off, whereas those less irritative to skins have been easyto peel off.

Therefore, research and development have been under way from theviewpoint of the elasticity of support, the adhesiveness of adhesivelayer, and the like in order to satisfy both high peeling prevention(resistance to peel) and low skin irritation (suppression of rashes inthe skin and pains upon peeling), and various patch agents have beenproposed. For example, Japanese Patent Application Laid-Open No. HEI9-255563 discloses a technique in which the ratio in length between thelonger and shorter sides in a rectangular patch agent and the bendingresistance in the longitudinal direction are controlled so as to yield askin traceability. Also, Japanese Patent Application Laid-Open No. HEI10-226638 discloses a technique in which a support having a low bendingresistance is provided with an adhesive planar substance, so as toprovide the support with a softness. Further, Japanese PatentApplication Laid-Open No. HEI 11-35453 discloses a patch agent whoseadhesive layer contains oleic acid alkyl ester, so as to reduce thepeeling force.

Even in the above-mentioned patch agents, however, if the adhesivenessof adhesive layer is fully lowered in order to prevent rashes fromoccurring, then the skin adhesion becomes insufficient, so that they areeasier to peel off. If a sufficient adhesiveness is provided thereto sothat they do not peel off even when applied to a part whose movement islarge, then the skin is likely to suffer a rash, whereas pains accompanythe peeling, where by a vicious circle occurs.

Thus, the conventional patch agents have not yet been sufficient forsatisfying opposite characteristics of high peeling prevention(resistance to peel) and low skin irritation (suppression of rashes inthe skin and pains upon peeling) with a favorable balance.

DISCLOSURE OF THE INVENTION

In view of the problems in the above-mentioned prior art, it is anobject of the present invention to provide a patch agent which is fullyprevented from peeling off at the time of application and fullysuppresses rashes in the skin and pains upon peeling.

The inventors repeatedly carried out diligent studies in order toachieve the above-mentioned object and, as a result, have found that, ifphysical properties are taken into consideration independently for thesupport and adhesive layer when studying the peeling prevention and skinirritation as in the prior art, then it is difficult to satisfy theseopposite characteristics at the same time; and that, when the bendingresistance and probe tack value of a patch agent itself constructed andintegrated by the support and adhesive layer satisfies predeterminedconditions, it yields a patch agent which is fully prevented frompeeling off when applied to parts such as joints and faces wheremovements are large and skins expand and constrict drastically, and therash of skin and the pain upon peeling are fully suppressed; whereby thepresent invention has been accomplished.

Namely, the patch agent of the present invention is a patch agentcomprising a support made of a synthetic fiber and an adhesive layermounted on the support, said patch agent having a bending resistance of10 to 30 mm and a probe tack value of 0.25 to 1.2 N.

According to the present invention, since the bending resistance ofpatch agent is 10 to 30 mm, and its probe tack value is 0.25 to 1.2 N,the skin traceability at the time of application is enhanced while theskin irritation is fully lowered, whereby it is fully prevented frompeeling off while rashes of skin and pains upon peeling are fullysuppressed.

The bending resistance refers to a value measured under the followingconditions by the 45° cantilever method defined by JIS L 1085. Namely,the bending resistance in accordance with the present invention refersto the distance [mm] by which a test piece of 2 cm (shorter side)×about15 cm (longer side) arranged on a horizontal table with smooth surfaceshaving a slanted face of 45° at one end and a scale on the upper facesuch that the shorter side of the test piece and the baseline of thescale coincide with each other is mildly slid in the direction of theslanted face until the center point of one of the shorter sides of thetest piece abuts against the slanted face. Though the patch agent of thepresent invention may comprise a release sheet attached to the surfaceof adhesive layer as will be explained later, the bending resistance ofpatch agent in the present invention refers to the bending resistance ofthe patch agent including no release sheet, i.e., the bending resistanceof the patch agent itself in which the support and the adhesive layerare integrated with each other.

The probe tack value in accordance with the present invention refers tothe value measured under the following conditions in conformity to themethod defined in ASTM D 2979. Namely, by using the probe tack testerdefined in ASTM D 2979, after one bottom face of a cylinder (probe) madeof Bakelite having a diameter of 5 mm and an adhesive layer surface of atest piece having a predetermined area are brought into contact witheach other at a contact load of 0.98±0.001 N/cm² for a contact time of1.0±0.01 seconds, the probe is separated from the adhesive layer surfacein the perpendicular direction of the latter at a separating speed of5±0.1 mm/s. The probe tack value in accordance with the presentinvention refers to the force [N] required at the time of separation.

As mentioned above, the patch agent of the present invention maycomprise a release sheet attached to the surface of the adhesive layer,and the release sheet preferably has a bending resistance of 60 to 160mm.

Preferably, the support used in the patch agent of the present inventionis made of a polyester fiber having a fiber size (a fiber fineness) of30 to 75 deniers, and has a weight per area of 80 to 120 g/m².

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic sectional view showing a preferred embodiment ofthe patch agent of the present invention;

FIG. 2 is an explanatory view showing an example of the method of usingthe patch agent of the present invention; and

FIG. 3 is an explanatory view showing an example of the method of usingthe patch agent of the present invention.

BEST MODES FOR CARRYING OUT THE INVENTION

In the following, preferred embodiments of the present invention will beexplained in detail with reference to the drawings when necessary. Inthe drawings, parts identical or equivalent to each other will bereferred to with numerals identical to each other.

FIG. 1 is a schematic sectional view showing a preferred embodiment ofthe patch agent of the present invention. In

FIG. 1, a patch agent 1 comprises a support 2 and an adhesive layer 3mounted on a surface thereof, whereas a release sheet 4, which is peeledoff at the time of use, is preferably attached to a surface of theadhesive layer 3. In thus configured patch agent 1 of the presentinvention, the above-mentioned bending resistance is 10 to 30 mm, andthe above-mentioned probe tack value is 0.25 to 1.2 N. Since the patchagent 1 itself has a bending resistance of 10 to 30 mm and a probe tackvalue of 0.25 to 1.2 N, it satisfies a sufficiently high peelingprevention (resistance to peel) and a sufficiently low skin irritation(suppression of rashes in the skin and pains upon peeling), which arecharacteristics usually opposing each other, at the same time.

Namely, if the above-mentioned two conditions are satisfied at the sametime, both of the support and adhesive layer constituting the patchagent can fully trace the skin, even without increasing the adhesivenessof patch agent, when applied to joints such as elbows and knees wheremovements are large and faces and the like where very minute movementsoccur continuously, whereby the skin irritation can be reduced whilekeeping a sufficiently high peeling prevention.

The bending resistance of the patch agent of the present inventionitself is 10 to 30 mm as mentioned above, preferably 10 to 25 mm. As thebending resistance of the patch agent is lower, its skin traceabilitytends to improve, whereby it is prevented from peeling off. However, ifthe bending resistance is less than the lower limit mentioned above,then the supportiveness becomes insufficient, so that the patch agentmay get entangled or wrinkled at the time of application, whereby itbecomes harder to handle. If the bending resistance of patch agentexceeds the upper limit mentioned above, by contrast, the skintraceability becomes insufficient, so that it is likely to peel off evenupon a little movement.

The probe tack value of the patch agent of the present invention itselfis 0.25 to 1.2 N as mentioned above, preferably 0.3 to 1.0 N. If theprobe tack value of patch agent is less than the lower limit mentionedabove, then the skin adhesiveness of patch agent becomes insufficient,so that it is likely to peel off even upon a little movement. If theprobe tack value of patch agent exceeds the upper limit mentioned above,on the other hand, the skin irritation increases so much that rashes inthe skin and pains upon peeling are likely to occur.

The support employed in the present invention is made of a syntheticfiber, and is not restricted in particular as long as the bendingresistance and probe tack value of the patch agent itself can satisfythe above-mentioned conditions. Preferably used as its constituentmaterial are films, woven fabrics, knitted fabrics, nonwoven fabrics, ortheir laminates comprising a synthetic resin such as a block copolymerresin mainly composed of polyester, polyethylene terephthalate (PET),ethylene/vinyl acetate copolymer (EVA), vinyl chloride, polyethylene,polybutadiene, styrene/butadiene, or styrene/isoprene,butadiene/styrene/methyl methacrylate copolymer resin, nylon,polyurethane, alkoxyalkyl (meth)acrylate copolymer, polyvinyl acetal,polyamide, or rayon. In particular, woven fabrics or nonwoven fabrics ofpolyester fiber yield a fine feeling and a favorable feel of use,whereby they are used more preferably in the patch agent of the presentinvention.

When a polyester woven fabric is used as the support in the patch agentof the present invention, it preferably has a weight per area of 80 to120 g/m² and a fiber size of 30 to 75 deniers. When the weight per areaand fiber size of the patch agent satisfy the conditions mentionedabove, it tends to yield a patch agent whose feeling and feel of usesuch as feel of touch are very fine having a flexibility and a very highskin traceability.

Preferably, the support used in the patch agent of the present inventionhas an appropriate elasticity. Specifically, the load at the time of 50%elongation (defined by JIS L1096) under the measurement condition with asample width of 50 mm, a sample length of 200 mm, and an elongationspeed of 200 mm/min is preferably 100 to 1500 g in the longitudinaldirection (longer side direction) and 200 to 3000 g in the lateraldirection, more preferably 100 to 1000 g in the longitudinal direction(longer side direction) and 200 to 2500 g in the lateral direction. The50% elongation recovery ratio (defined by JIS L1096) under themeasurement condition with a sample width of 50 mm, a sample length of200 mm, and an elongation speed of 200 mm/min is preferably 75% to 95%in the longitudinal direction (longer side direction) and 65% to 90% inthe lateral direction, more preferably 80% to 95% in the longitudinaldirection (longer side direction) and 70% to 90% in the lateraldirection. If the load at the time of 50% elongation is less than theabove-mentioned lower limit, then the supportiveness (nerve) of patchagent becomes insufficient, whereby the handling characteristic inattaching operations tends to deteriorate. If the load at the time of50% elongation exceeds the above-mentioned upper limit, on the otherhand, then the skin adhesiveness becomes insufficient, whereby the patchagent tends to be insufficiently prevented from peeling when applied toa bending part for a long period of time. If the 50% elongation recoveryratio is less than the above-mentioned lower limit, then the skintraceability becomes insufficient when the patch agent is applied to abending part, whereby the patch agent tends to be insufficientlyprevented from peeling. If the 50% elongation recovery ratio exceeds theabove-mentioned upper limit, on the other hand, then the handlingcharacteristic at the time of attaching operations tends to deteriorate.

Preferably, the support used in the patch agent of the present inventionhas a thickness of 0.01 to 5 mm. If the thickness of support is lessthan the above-mentioned lower limit, then the handling characteristicin attaching operations deteriorates, so that the patch agent tends toget entangled or wrinkled and becomes harder to apply finely. If thethickness of support exceeds the above-mentioned upper limit, on theother hand, then the softness of patch agent becomes insufficient, sothat there is a tendency that, at the time of application, a sense ofincompatibility such as twitch is felt, and physical irritations arelikely to be provided.

When the patch agent of the present invention is employed as a plasteragent, an adhesive layer mainly composed of a pressure-sensitiveadhesive is mounted on the above-mentioned support. Here, though thematerial constituting the adhesive layer is not restricted in particularas long as the bending resistance and probe tack value of the patchagent itself can satisfy the above-mentioned conditions, one which canfix a medicine onto a skin surface for a long time at room temperatureis preferably used. Specific examples of such a material include acrylicadhesives, rubber adhesives, silicone adhesives, and the like. Amongthem, using rubber adhesives is more preferred since the physicalproperties of adhesive and the releasability of medicine are favorable.In particular, natural rubber, synthetic isoprene rubber,polyisobutylene rubber, polyvinyl ether, polyurethane, polyisoprene,polybutadiene, styrene/butadiene copolymer, styrene/isoprene copolymer,and styrene/isoprene/styrene block (SIS) copolymer are more preferablyused. Further, when SIS copolymer is used, SIS bases manufactured byShell Chemicals Ltd. (under the trade names of Califlex TR-1107,Califlex TR-1111, Califlex TR-1112, and Califlex TR-1117), SIS basesmanufactured by Japan Synthetic Rubber Co., Ltd. (under the trade namesof JSR5000, JSR5002, and JSR5100), and an SIS base manufactured byNippon Xeon Co., Ltd. (under the trade name of Quintac 3570C) are usedmost preferably.

When necessary, compounding agents such as tackifiers, softeners,fillers, age resistors, and absorption accelerators may be added to theadhesive layer used in the present invention. Examples of suchcompounding agents include tackifiers such as alicyclic saturatedhydrocarbon resins (manufactured by Arakawa Chemical Industries, Ltd.under the trade names of Alcon P-100 and the like), hydrogenated rosinesters (manufactured by Arakawa Chemical Industries, Ltd. under thetrande names of KE-311 and KE-100, and manufactured by HerculesIncorporated under the trade names of Foral 105, Foral 85, and thelike), hydrogenated alicyclic hydrocarbons (manufactured by ExxonChemical Co. under the trade names of Escorez 5300 and the like),polyterpene resins, petroleum resins, and phenol resins; softeners suchas liquid paraffin, polybutene, liquid polyisobutyrene, and animal andvegetable oils; other fillers; age resistors; and the like. Also, whennecessary, absorption accelerators may be added to the above-mentionedpressure-sensitive adhesive in order to improve the skin permeability ofmedicine. Examples of such absorption accelerators include isopropylmyristate, diethyl sebacate, sorbitan monolaurate, sodiumoleylphosphate, sodium laurylsulfate, octylphenyl ethers, lauryl ethers,sorbitan monolaurate, lauroyl diethanolamide, lauroyl sarcosine, oleoylsarcosine sugar esters, lecithin, glycyrrhizin, urea, salicylic acid,calcium thioglycolate, lactic acid, lactic acid esters, olive oil,squalene, lanolin, liquid paraffin, glycerin, and the like. Further,when necessary, pigments, flavors, UV-absorbents, surfactants,pH-adjusters, and the like may appropriately be compounded in theabove-mentioned pressure-sensitive adhesive.

When the patch agent of the present invention is employed in a poulticeagent, an adhesive layer mainly composed of a moisture-containingointment is mounted on the above-mentioned support. Here, though thematerial constituting the moisture-containing ointment is not restrictedin particular as long as the bending resistance and probe tack value ofthe patch agent itself can satisfy the above-mentioned conditions, onewhich can fix amedicine onto a skin surface for a long time at roomtemperature is preferable. Water, thickeners, wetting agents, andfillers, and, when necessary, cross linking agents, polymerizers,solubilizers, absorption accelerators, efficacy adjuvants, stabilizers,antioxidants, emulsifiers, effective agents, and the like are added.

As the thickeners used in the moisture-containing ointment in accordancewith the present invention, those which can stably hold a moisture of30% to 80% and have a water retention are preferable. Preferablyemployable as specific examples thereof are water-soluble polymers suchas natural polymers including those of vegetable type such as guar gum,locust bean gum, carrageenan, alginic acid, sodium alginate, agar, gumarabic, tragacanth gum, karaya gum, pectin, and starch, microorganictype such as xanthan gum and acacia gum, and animal type such as gelatinand collagen; semi-synthetic polymers including those of cellulose typesuch as methyl cellulose, ethyl cellulose, hydroxyethyl cellulose, andsodium carboxymethyl cellulose, and starch type such as soluble starch,carboxymethyl starch, and dialdehyde starch; and synthetic polymersincluding those of vinyl type such as polyvinyl alcohol, polyvinylpyrrolidone, and polyvinyl methacrylate, acrylic type such aspolyacrylic acid and sodium polyacrylate, and other synthetic polymerssuch as polyethylene oxide and methyl vinyl ether/maleic anhydridecopolymer.

In particular, as such a thickener, polyacrylic acid is preferable inthat it has a high gel strength and is excellent in water retention, andsodium polyacrylate having an average degree of polymerization of 20000to 70000 is more preferable. As the average degree of polymerizationbecomes lower than 20000, the thickening effect tends to decrease, sothat a sufficient gel strength may not be obtained. As the averagedegree of polymerization becomes higher than 70000, on the other hand,the thickening effect tends to become so strong that the operability maylower.

Examples of wetting agents employed in the moisture-containing ointmentinclude polyhydric alcohols such as glycerin, propylene glycol, andsorbital; examples of fillers include kaolin, zinc oxide, talc,bentonite, aluminum silicate, titanium oxide, aluminum metasilicate,calcium sulfate, and calcium phosphate.

Also, propylene carbonate, crotamiton, L-menthol, mentha oil, limonene,diisopropyl adipate, and the like as a solubilizer or absorptionaccelerator; and methyl salicylate, glycol salicylate, L-menthol,thymol, mentha oil, limonene, nonylic acid vanillylamide, pepperextract, and the like as an efficacy adjuvant may be added to themoisture-containing ointment in accordance with the present invention.Further, when necessary, stabilizers, antioxidants, emulsifiers, and thelike may be added to the moisture-containing ointment in accordance withthe present invention.

Further, when necessary, crosslinking agents, polymerizers, and the likemay be added to the moisture-containing ointment so as to strengthen themoisture-containing ointment (adhesive) and cause it to yield waterretention. Such crosslinking agents and polymerizers can appropriatelybe chosen according to the kind of thickeners and the like.

For example, in the case where polyacrylic acid or polyacrylate isemployed as a thickener, compounds having at least two pieces of epoxygroup in a molecule; inorganic acid salts such as hydrochlorides,sulfates, phosphates, and carbonates of Ca, Mg, Al, and the like;organic acid salts such as citrates, tartrates, gluconates, andstearates; oxides such as zinc oxide and silicic anhydride; andpolyvalent metal compounds such as hydroxides like aluminum hydroxideand magnesium hydroxide are preferably used. In the case where polyvinylalcohol is employed as a thickener, adipic acid, thioglycolic acid,epoxy compounds (epichlorohydrin), aldehydes, N-methylol compounds, andcomplexes of Al, Ti, Zr, Sn, V, Cu, B, and Cr are preferably used. Whenpolypyrrolidone is employed as a thickener, methyl vinyl ester/maleicanhydride copolymer, polyacid compounds, or alkali metal salts(polyacrylic acid, tannic acid, and their derivatives) are preferablyused. When polyethylene oxide is employed as a thickener, peroxide orpolysulfone azide is preferably used. When methyl vinyl ether/maleicanhydride copolymer is employed as a thickener, polyfunctional hydroxylcompounds, polyamines, iodine, gelatin, polyvinyl pyrrolidone, iron,mercury, and lead salts are preferably used. When gelatin is employed asa thickener, aldehydes such as formaldehyde, glutaraldehyde, dialdehydestarch; diepoxides such as glyoxal and butadiene oxide; diketones suchas divinyl ketone; and diisocyanates are preferably used.

When thus configured plaster agent, poultice agent, or the like iscaused to hold a medicine, it will be sufficient if the medicine iscompounded in the adhesive layer thereof. Examples of the medicine usedin the patch agent of the present invention include general anesthetics,hypnotic analgesics, antipyretic/antiphlogistic analgesics, steroidhormone drugs, analeptics/stimulants, psychiatric/neurological drugs,local anesthetics, skeletal muscle relaxants, drugs for autonomicnerves, antiallergic agents, antihistamine agents, cardiotonics, drugsfor arrhythmia, diuretics, hypotensive agents, vasoconstrictors,vasodilators, calcium antagonists, antibacterial/bactericidal agents,drugs for parasitic dermatosis, skin softeners, antibiotics, antidotes,cough remedies, antipruritics, sleeping drugs, psychiatric activators,drugs for asthma, hormone secretion accelerators, antiulcer agents,anticancer drugs, vitamin compounds, and those having a whitening effectsuch as skin care components.

The thickness (coating thickness) of the adhesive layer mounted on thesupport in the patch agent of the present invention is preferably 0.05to 3 mm. If the thickness of adhesive layer exceeds 3 mm, then thereleasability of the medicine contained in the adhesive layer tends tolower. If it is less than 0.05 mm, on the other hand, then the skinadhesiveness tends to lower, so that the peel-off may not fully beprevented from occurring.

Preferably, the thickness including the support and the thickening agentin the patch agent of the present invention (the thickness of patchagent) is 0.3 to 5 mm. If the thickness of patch agent exceeds 5 mm,then edges of the patch agent tend to catch on cloths and the like atthe time of application, thereby peeling off. If the thickness of patchagent is less than 0.3 mm, on the other hand, then the supportiveness ofpatch agent tends to lower, thereby generating such phenomena as failingto securely attach to a part to be applied, entangling, and wrinklingafter application.

Preferably, corners in the patch agent of the present invention are cutin arc forms. Once a poultice agent partly turns over and peels off,horny layers of skin and dust attach to this part, which makes itdifficult for the poultice agent to be applied again. When the patchagent has a rectangular form in particular, corners tend to catch oncloths and the like and turn over at first, thereby peeling off.Therefore, it is preferred that corners of the patch agent be formedlike an arc, so as to be unlikely to catch on cloths and the like,whereby the peel-off tends to be more effectively prevented fromoccurring.

When corners in the poultice agent of the present invention are formedlike an arc, it is preferred that the arc have a radius of curvature (R)of 5 to 20 mm. If the radius (R) is less than 5 mm, then the reductionin peel-off at the time of application tends to be achievedinsufficiently. If it exceeds 20 mm, on the other hand, then thephenomenon of peeling off from corners is prevented from occurring, butthe loss at the time of manufacture tends to be so large that themanufacturing cost increases, which is poor in actual profit.

In the patch agent of the present invention, it is preferred that arelease sheet having an appropriate bending resistance be attached to asurface of the adhesive layer thereof. Specifically, it is preferredthat a release sheet having a bending resistance of 60 to 160 mm beattached thereto. Attaching such a release sheet to the patch agentimproves the supportiveness of patch agent, whereby the patch agenttends to be applied finely and securely without generating entanglement,wrinkles, and the like. If the bending resistance of release sheet isless than 60 mm, then the supportiveness tends to become insufficient,so that the patch agent may twist and get entangled or wrinkle afterbeing applied. If the bending resistance of release sheet exceeds 160mm, on the other hand, then the release sheet becomes harder, wherebythe operability at the time of peeling off the release sheet from thepoultice agent tends to lower.

The material for such a release sheet is not restricted in particular aslong as the bending resistance of release sheet satisfies the conditionmentioned above. Specifically, plastic films such as cast polypropylene(CPP), oriented polypropylene (OPP), polyethylene terephthalate (PET),polybutylene terephthalate (PBT), polyethylene, polyester, polyurethane,polyvinyl chloride, and polystyrene, silicone-treated paper such assilicone-treated synthetic resin, synthetic paper, and synthetic fiber,aluminum foil, and laminate-processed paper in which polyethylene or thelike is laminated on kraft paper, which are left uncolored or colored,are preferably used. Among them, polyethylene terephthalate (PET) ispreferably used in particular.

The thickness of the release sheet used in the patch agent of thepresent invention is preferably 10 to 100 μm, more preferably 30 to 90μm, further preferably 40 to 85 μm. If the release sheet has a thicknessof less than 10 μm, then it is harder to hold and more likely to getentangled with the adhesive layer when peeling off the release sheet. Onthe other hand, though the release sheet becomes easier to hold as itsthickness increases, if it exceeds 100 μm, then it becomes difficult tocut the raw material sheet, whereby the operability (manufacturingefficiency) tends to lower.

The release sheet used in the patch agent of the present inventionpreferably has a continuous or intermittent cutting portion at apredetermined part such as a substantially center part thereof. Usingare lease sheet having a cutting portion tends to be effective in notonly improving the feel of use in that it can be applied finely andsecurely without soiling hands, but also improving the workingefficiency in that an operation for peeling off the release sheet and anoperation for applying the patch agent can be carried out at the sametime.

Namely, when the patch agent of the present invention comprises arelease sheet having a cutting portion, it can be used in conformitywith the method of use explained in the following. FIG. 2 is anexplanatory view showing an operation for severing the release sheet 4of patch agent 1, whereas FIG. 3 is an explanatory view showing anoperation for attaching the patch agent 1 to a part to be applied.First, as shown in FIG. 2, both ends of the patch agent 1 are picked,the release sheet 4 is pulled together with the support 2, and thecutting portion is slightly bent, whereby the release sheet 4 canlaterally be severed along the cutting portion. When apart of thecutting portion is just slightly bent, the severed release sheet 4 turnsup from the severed portion due to the elasticity of release sheet, thusexposing the adhesive layer 3. Then, as shown in FIG. 3, while thusexposed adhesive layer is brought into contact with an affected part,the individual turned-up parts are pulled left ward and right ward,respectively, and peeled off, whereby the operation for peeling off therelease sheet 4 and the operation for attaching the patch agent 1 to theaffected part are carried out at the same time. Thus, using the patchagent comprising a release sheet having a cutting portion tends toimprove the feel of use and operating efficiency of the patch agent.

EXAMPLES

In the following, the present invention will be explained morespecifically with reference to Examples and Comparative Examples, thoughthe present invention will not be restricted to the following examplesat all.

Example 1

Into a mixer, 70 parts by weight of purified water, 3 parts by weight ofgelatin, 2 parts by weight of polyvinyl alcohol, and 2 parts by weightof kaolin were introduced; and they were mixed at a temperature of about50° C., whereby a uniform dispersion was obtained. Then, a dispersionprepared beforehand comprising 13 parts by weight of glycerin, 5 partsby weight of sodium polyacrylate, 2 parts by weight of methyl vinylether/maleic anhydride copolymer, and 1 part by weight of aluminumhydroxide were added to the former dispersion, and stirred and mixedtherewith. Further, a solution in which 0.5 part by weight of ketoprofenwas dissolved into 1.5 parts by weight of mentha oil was added theretoand stirred and mixed together, whereby a uniform mixture was obtained.

Subsequently, thus obtained mixture was spread over a polypropylene film(having a bending resistance of 75 mm) such that the weight after dryingbecame 10 g/140 cm², and then covered with a support made of polyesterwoven fabric (having a fiber size of 75 deniers and a weight per area of120 g/m²) so as to be transferred thereto under pressure. Thus obtainedproduct was cut, such that the aimed patch agent was obtained as apoultice agent having a length of 10 cm, a width of 14 cm, and athickness of 2.00 mm.

Example 2

Into a mixer, 31.92 parts by weight of purified water, 3 parts by weightof gelatin, 3 parts by weight of polyvinyl pyrrolidone, and 3 parts byweight of zinc oxide were introduced; and they were mixed at atemperature of about 50° C., whereby a uniform dispersion was obtained.Then, a dispersion prepared beforehand comprising 50 parts by weight ofpolyethylene glycol, 4 parts by weight of sodium polyacrylate, 3 partsby weight of polyacrylic acid, and 0.08 parts by weight of polyethyleneglycol diglycidyl ether were added to the former dispersion, and stirredand mixed therewith. Further, a solution in which 0.5 part by weight ofsuprofen was dissolved into 1.5 parts by weight of benzyl alcohol wasadded thereto and stirred and mixed therewith, whereby a uniform mixturewas obtained.

Subsequently, thus obtained mixture was spread over a polyethylene film(having a bending resistance of 130 mm) such that the weight afterdrying became 5 g/140 cm², and then covered with polypropylene wovenfabric (having a fiber size of 35 deniers and a weight per area of 110g/m²) so as to be transferred thereto under pressure. Thus obtainedproduct was cut, such that the aimed patch agent was obtained as apoultice agent having a length of 10 cm, a width of 14 cm, and athickness of 2.00 mm.

Example 3

Into 78.4 parts by weight of purified water, 4 parts by weight ofsynthetic aluminum silicate was dispersed. Then, 1 part by weight ofgelatin, 0.05 part by weight of sorbitol polyglycidyl ether, 0.2 part byweight of water-soluble placenta extract, 0.1 part by weight ofallantoin, and 0.25 part by weight of methyl paraben were added theretoand mixed together. Further, 6 parts by weight of sodium polyacrylateand 10 parts by weight of polyethylene glycol were added thereto andstirred together, whereby a uniform mixture was obtained.

Subsequently, thus obtained mixture was spread over a polyester film(having a bending resistance of 120 mm) such that the weight afterdrying became 10 g/140 cm², and then covered with polyester woven fabric(having a fiber size of 60 deniers and a weight per area of 110 g/m²) soas to be transferred thereto under pressure. Thus obtained product wascut, such that the aimed patch agent was obtained as a sheet-like packagent having a length of 10 cm, a width of 14 cm, and a thickness of2.00 mm.

Example 4

In a nitrogen gas atmosphere, 26 parts by weight ofstyrene/isoprene/styrene block copolymer (Krayton D-1107CU manufacturedby Shell Chemicals), 22 parts by weight of polyisobutylene (Opanol B80manufactured by BASF), 10 parts by weight of hydrogenated rosin ester(Stebelite Ester 7 manufactured by Rika-Hercules), 38 parts by weight ofliquid paraffin (Crystol J-352 manufactured by Esso Oil), and 1 part byweight of dibutyl hydroxytoluene were heated and stirred for 60 minutesat 200° C., whereby a solution was obtained. To this solution, 3 partsby weight of ketoprofen were added at 150° C. (110 to 200° C.); and theywere mixed for 15 minutes, whereby a uniform mixture was obtained.

Subsequently, thus obtained mixture was spread over a silicone-treatedpolyester film (having a bending resistance of 65 mm) such that theweight after drying became 1 g/70 cm², and then covered with polyesterwoven fabric (having a fiber size of 50 deniers and a weight per area of80 g/m²) so as to be transferred thereto under pressure. Thus obtainedproduct was cut, such that the aimed patch agent was obtained as a tapeagent having a length of 7 cm, a width of 10 cm, and a thickness of 0.60mm.

Example 5

In a nitrogen gas atmosphere, 23 parts by weight ofstyrene/isoprene/styrene block copolymer (Krayton D-KX401CS manufacturedby Shell Chemicals), 22 parts by weight of polyisobutylene (VistanexMML-80 manufactured by Exxon Chemical), 23 parts by weight of petroleumresin (Escorez 5300 manufactured by Exxon Chemical), 24 parts by weightof liquid paraffin (Crystol J-352 manufactured by Esso Oil), and 3partsby weight of titanium oxide were heated and stirred for 60 minutes at200° C., whereby a solution was obtained. To this solution, 5 parts byweight of diclofenac sodium were added at 150° C; and they were mixedfor 15 minutes, whereby a uniform solution was obtained.

Subsequently, thus obtained solution was spread over a silicone-treatedpolyester film (having a bending resistance of 160 mm) such that theweight after drying became 1 g/70 cm², and then covered with polyesterwoven fabric (having a fiber size of 30 deniers and a weight per area of120 g/m²) so as to be transferred thereto under pressure. Thus obtainedproduct was cut, such that the aimed patch agent was obtained as a tapeagent having a length of 7 cm, a width of 10 cm, and a thickness of 0.75mm.

Example 6

In a nitrogen gas atmosphere, 16 parts by weight ofstyrene/isoprene/styrene block copolymer (Krayton D-KX401CS manufacturedby Shell Chemicals), 10 parts by weight of polyisobutylene (VistanexMML-100 manufactured by Exxon Chemical), 25 parts by weight ofhydrogenated rosin glycerin ester (manufactured by Arakawa ChemicalIndustries), 36 parts by weight of liquid paraffin (Crystol J-352manufactured by Esso Oil), and 3 parts by weight of synthetic aluminumsilicate were heated and stirred for 60 minutes at 200° C., and then 5parts by weight of methyl salicylate and 5 parts by weight of L-mentholwere further added thereto at 150° C. and mixed for 15 minutes, wherebya uniform mixture was obtained.

Subsequently, thus obtained mixture was spread over a silicone-treatedpolyester film (having a bending resistance of 160 mm) such that theweight after drying became 1 g/70 cm², and then covered with polyesterwoven fabric (having a fiber size of 75 deniers and a weight per area of80 g/m²) so as to be transferred thereto under pressure. Thus obtainedproduct was cut, such that the aimed patch agent was obtained as a tapeagent having a length of 7 cm, a width of 10 cm, and a thickness of 0.55mm.

Comparative Example 1

Into a reactor, 55 parts by weight of acrylic acid 2-ethylhexyl ester,26 parts by weight of acrylic acid methoxyethyl ester, 14.7 parts byweight of vinyl acetate, 0.3 part by weight of azobisisobutyronitrile,and 100 parts by weight of ethyl acetate were introduced. Subsequently,they were heated to 60° C. in a nitrogen atmosphere so as to initiatepolymerization, the reaction was carried out for 10 hours, and then themixture was further matured for 2 hours at 60° C., whereby a copolymersolution was obtained. To thus obtained copolymer solution, 4 parts byweight of ketoprofen were added; and they were mixed together, whereby auniform mixture solution was obtained.

Thus obtained mixture was spread over a silicone-treated polyester film(having a bending resistance of 120 mm) such that the weight afterdrying became 0.5 g/70 cm², and then covered with polyester woven fabric(having a fiber size of 35 deniers and a weight per area of 90 g/m²) soas to be transferred thereto under pressure. Thus obtained product wascut, such that the aimed patch agent was obtained as a tape agent havinga length of 7 cm, a width of 10 cm, and a thickness of 0.45 mm.

Comparative Example 2

Into a reactor, 47.47 parts by weight of purified water, 1 part byweight of agar, 2 parts by weight of polyvinyl alcohol, and 2 parts byweight of titanium oxide were introduced; and they were dissolved at atemperature of about 50° C., whereby a uniform dispersion was obtained.Subsequently, a dispersion prepared beforehand comprising 26 parts byweight of glycerin, 15 parts by weight of sorbitol, 5.7 parts by weightof sodium polyacrylate, and 0.03 part by weight of polyglycerolpolyglycidyl ether was added thereto, and stirred and mixed therewith.Further, a solution in which 0.3 part by weight of crotamiton and 0.5part by weight of piroxi cam were dissoluted was added thereto, andstirred and mixed therewith, whereby a uniform mixture was obtained.

Thus obtained mixture was spread over a polyethylene film (having abending resistance of 40 mm) such that the weight after drying became 5g/140 cm², and then covered with a support made of polyester wovenfabric (having a fiber size of 35 deniers and a weight per area of 60g/m²) so as to be transferred thereto under pressure. Thus obtainedproduct was cut, such that the aimed patch agent was obtained as apoultice agent having a length of 10 cm, a width of 14 cm, and athickness of 0.80 mm.

Comparative Example 3

In a nitrogen gas atmosphere, 26 parts by weight ofstyrene/isoprene/styrene block copolymer (Krayton D-1107CU manufacturedby Shell Chemicals), 8 parts by weight of hydrogenated rosin glycerinester (manufactured by Arakawa Chemical Industries), 55 parts by weightof liquid paraffin (Crystol J-352 manufactured by Esso Oil), and 3 partsby weight of synthetic aluminum silicate were heated and stirred for 60minutes at 200° C., and then 3 parts by weight of ketoprofen and 5 partsby weight of L-menthol were further added thereto at 150° C. and mixedfor 15 minutes, whereby a uniform mixture was obtained.

Subsequently, thus obtained mixture was spread over a silicone-treatedpolyester film (having a bending resistance of 180 mm) such that theweight after drying became 1 g/70 cm², and then covered with a supportmade of polyester woven fabric (having a fiber size of 25 deniers and aweight per area of 60 g/m²) so as to be transferred thereto underpressure. Thus obtained product was cut, such that the aimed patch agentwas obtained as a tape agent having a length of 7 cm, a width of 10 cm,and a thickness of 0.50 mm.

Comparative Example 4

In a nitrogen gas atmosphere, 17 parts by weight ofstyrene/isoprene/styrene block copolymer (SIS-5000 manufactured by JapanSynthetic Rubber), 52 parts by weight of hydrogenated rosin glycerinester (manufactured by Arakawa Chemical Industries), and 21 parts byweight of liquid paraffin (Crystol J-352 manufactured by Esso Oil) wereheated and stirred for 60 minutes at 200° C., whereby a solution wasobtained. To this solution, 5 parts by weight of glycol salicylate and 5parts by weight of L-menthol were further added at 150° C. and mixed for15 minutes, whereby a uniform mixture was obtained.

Subsequently, thus obtained mixture was spread over a silicone-treatedpolyester film (having a bending resistance of 100 mm) such that theweight after drying became 1 g/70 cm², and then covered with a supportmade of polyvinyl chloride film (having a weight per area of 110 g/m²)so as to be transferred thereto under pressure. Thus obtained productwas cut, such that the aimed patch agent was obtained as a tape agenthaving a length of 7 cm, a width of 10 cm, and a thickness of 0.25 mm.

Table 1 shows the bending resistance and probe tack value of each ofthus obtained patch agents.

TABLE 1 BENDING RESISTANCE PROBE TACK VALUE (mm) (N) EXAMPLE 1 22 0.44EXAMPLE 2 18 0.73 EXAMPLE 3 30 0.25 EXAMPLE 4 10 0.83 EXAMPLE 5 20 1.10EXAMPLE 6 15 0.78 COMP. EX. 1 14 1.76 COMP. EX. 2  7 0.20 COMP. EX. 3 120.15 COMP. EX. 4 40 2.75

Next, the following evaluation tests were carried out while using theindividual patch agents of Examples 1 to 6 and Comparative Examples 1 to4.

Sensory Application Test

Concerning the feel of use of each of the patch agents of Examples 1 to6 and Comparative Examples 1 to 4, a sensory attachment test was carriedout for 30 normal adult males. Namely, the testers applied theindividual patch agents to elbows on different days, performed anoperation of peeling them off after 6 hours of application, andevaluated three evaluation items of “easiness to apply at the time ofapplying operation,” “resistance to peel at the time of application,”and “pain at the time of peel-off” according to their correspondingcriteria shown in Table 2. Thus obtained results are shown in Table 2.The evaluations in Table 2 are classified according to the number ofitems in which the number of testers who did the worst evaluations of“hard to apply,” “¼ or more peeled off,” and “pain” was 5 or more, suchthat rank A refers to the case where the number of items correspondingthereto among the above-mentioned three items was 0, rank B refers tothe case where the number was 1, and rank C refers to the case where thenumber was 2 or greater.

TABLE 2 EASINESS TO APPLY RESISTANCE TO PEEL NEITHER EDGE ¼ HARD HARDNOR EASY NO PORTION OR MORE TO APPLY EASY TO APPLY PEEL-OFF PEELEDPEELED (PERSON) (PERSON) (PERSON) (PERSON) (PERSON) (PERSON) EXAMPLE 1 14 25 23 5 2 EXAMPLE 2 2 6 22 25 4 1 EXAMPLE 3 0 5 25 22 6 2 EXAMPLE 4 45 21 25 5 0 EXAMPLE 5 0 4 26 27 2 1 EXAMPLE 6 3 5 22 26 4 0 COMP. EX. 15 6 19 28 2 0 COMP. EX. 2 18 12 0 10 8 12 COMP. EX. 3 24 6 0 5 8 7 COMP.EX. 4 5 12 13 27 2 1 PAIN UPON PEELING NO SLIGHT PAIN PAIN PAIN (PERSON)(PERSON) (PERSON) EVALUATION EXAMPLE 1 28 2 0 A EXAMPLE 2 24 6 0 AEXAMPLE 3 29 1 0 A EXAMPLE 4 26 4 0 A EXAMPLE 5 24 4 2 A EXAMPLE 6 23 61 A COMP. EX. 1 0 3 27 C COMP. EX. 2 30 0 0 C COMP. EX. 3 26 4 0 C COMP.EX. 4 2 4 24 CSkin Safety Test (Normal Subject Patch Test)

In the above-mentioned sensory application test, the state of skin atthe part of application after peeling off each patch agent is evaluatedaccording to the following criteria:

-   -   −: no reaction;    -   ±: erythema is slightly seen;    -   +: erythema is clearly seen;    -   ++: erythema, and papule or edema are seen; and    -   +++: erythema, papule or edema, and vesicle are seen.        Thus obtained results are shown in Table 3. The evaluations in        Table 3 are classified such that rank A refers to the case where        the ratio of occurrence of ± to +++ in the above-mentioned        criteria is 10% or less, rank B refers to the case where the        ratio is more than 10% but not exceeding 25%, and rank C refers        to the case where the ratio exceeds 25%.

TABLE 3 EVALUATION +++ ++ + ± − TOTAL (PERSON) (PERSON) (PERSON)(PERSON) (PERSON) (PERSON) EVALUATION EXAMPLE 1 0 0 0 1 29 30 A EXAMPLE2 0 0 0 2 28 30 A EXAMPLE 3 0 0 0 0 30 30 A EXAMPLE 4 0 0 0 3 27 30 AEXAMPLE 5 0 0 0 2 28 30 A EXAMPLE 6 0 0 0 2 28 30 A COMP. EX. 1 0 0 0 1119 30 C COMP. EX. 2 0 0 0 2 28 30 A COMP. EX. 3 0 0 0 3 27 30 A COMP.EX. 4 0 0 0 10 20 30 C

Table 4 shows the total evaluation according to the results of sensoryapplication test and skin safety test mentioned above. The criteria forthe total evaluation in Table 4 are as follows:

-   -   A: both of the above-mentioned tests are evaluated A;    -   B: one of the above-mentioned tests is A to B, whereas the other        is B;    -   C: one of the above-mentioned tests is A to B, whereas the other        is C; and    -   D: both of the above-mentioned tests are evaluated C.

TABLE 4 EVALUATION SENSORY SKIN APPLICATION SAFETY TEST TEST (RESISTANCETOTAL (FEEL OF USE) TO RASH) EVALUATION EXAMPLE 1 A A A EXAMPLE 2 A A AEXAMPLE 3 A A A EXAMPLE 4 A A A EXAMPLE 5 A A A EXAMPLE 6 A A A COMP.EX. 1 C C D COMP. EX. 2 C A C COMP. EX. 3 C A C COMP. EX. 4 C C D

As shown in Tables 2 to 4, it was verified that each of the patch agentsof examples 1 to 6 was an excellent patch agent yielding favorable feelof use in all the items of the easiness to apply, resistance to peel,and pain at the time of peeling, while fully suppressing the rash ofskin.

By contrast, the patch agents of Comparative Examples 1 and 4accompanied pains at the time of peeling, though they were hard to peeloff, and the ratio of occurrence of rash was high. Though the ratio ofoccurrence of rash was low, the patch agents of Comparative Examples 2and 3 were insufficient in terms of the easiness to apply and resistanceto peel, thereby failing to yield favorable feel of use.

INDUSTRIAL APPLICABILITY

As explained in the foregoing, the present invention yields a patchagent which is fully prevented from peeling off at the time ofapplication and fully suppresses the rash of skin and the pain uponpeeling.

1. A patch agent comprising a support made of a synthetic fiber and anadhesive layer mounted on said support, said patch agent having abending resistance of 10 to 30 mm and a probe tack value of 0.25 to 1.2N.
 2. A patch agent according to claim 1, wherein said patch agentcomprises a release sheet attached to a surface of said adhesive layer,said release sheet having a bending resistance of 60 to 160 mm.
 3. Apatch agent according to claim 1, wherein said support is made of apolyester fiber having a fiber size of 30 to 75 deniers, and has aweight per area of 80 to 120 g/m².